IXC invex therapeutics ltd

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    Good stuff researching and worthwhile comments in here, i'll add to it a little to give a clearer picture of the drugs background and IIH.

    Noteworthy top 20 shareholders are Andrew Forrest/Twiggy's foundation and Tony Grist of IInet...Top 20 hold around 80% and 50% of stock is actually Escrowed anyway.

    - *Exenatide, is a glucagon like peptide-1 receptor agonist. In 2005, Amylin Pharmaceuticals and Eli Lilly & Co. received a first approval for Exenatide for the treatment of type II diabetes in the US. Byetta is administered as a twice-daily subcutaneous injection and commercialised by AstraZeneca.

    - A Phase II Proofof Concept clinical trial managed by Invex/Dr Sinclair (founder) is currently underway exploring the physiological effects of Exenatide in reducing intracranial pressure in patients with IIH. The last patient has now been dosed and the last dosage of their 12 weeks would fall in the first or second week on January 2020. The data should be relatively easy to produce reports and is essentially just acting to say it is safe.

    -
    For orphan indications, such as IIH, this is a well-defined regulatory route, marketing approval usually requires only a single phase II clinical study. In addition, ODD’s also typically benefit from shorter regulatory review times. Once the drug is approved, the ODD helps provide protection from competition for up to 7 and 10 years respectively in the US and European Union (EU)....so if we are first to market then nobody can compete with us!

    -
    Invex intends to immediately engage with regulators, such as the US FDA and the EMA, to define and agree the design of a phase II registration study for its re purposed Exenatide in patients with IIH. As Invex has already received Orphan Drug Designations for Exenatide, a registration study in IIH is likely to be all that is required for marketing approval. So after the next trial the product can be marketed and on the shelf very quickly compared to most other listed companies who can take years and years to get something to market.

    - The re purposed drug can potentially de injected similar to an Epi-pen, these can be sourced from a number of manufacturers who should also able to provide Invex specified packaging, ready for supply to distributors. Again very easy to get the product on the market and ready to use in a cost effective manner.

    - Invex intends to seek marketing partnerships with major pharmaceutical companies for commercialisation in large markets such as the EU and US. The Company also intends to consider developing a direct sales capability in Australia. This approach is a well-established and generally successful route to market for smaller biopharmaceutical companies and will serve as a means of generating a return for shareholders either through revenue generation under licensing agreements (upfront, milestone and royalty payments) or through the outright sale of assets of the Company.

    So in a nut shell after the last patient finishes in Jan, results can be swiftly accumulated and analyzed to show it is safe in reducing IIH. The next trial would be the only other trial that needs to be done before getting a product to market in quick fashion.....then after IIH is cleared i daresay the company will move onto other indications such as Brain Injuries and Space travel....if it isn't eventually bought out by someone who will add it to their list of products.

    Only $40m Mcap with $10m in cash...no brainer IMO
 
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